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US Halts Foreign Drug Plant Inspections

The FDA halted nearly all inspections of overseas plants that ship drugs, medical devices and other consumer goods to the U.S.

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WASHINGTON (AP) — The Food and Drug Administration on Tuesday halted nearly all inspections of overseas plants that ship drugs, medical devices and other consumer goods to the U.S., citing the global spread of the coronavirus.

The agency announced it will postpone most foreign inspections scheduled through April, because of federal guidelines prohibiting travel for government workers. Last month, it postponed most inspections in China.

The FDA is responsible for ensuring that food, drugs, cosmetics, medical supplies and other U.S. imports are produced in safe, sanitary conditions that meet quality standards. Last year, it conducted more than 3,100 foreign inspections, according to agency records.

But regulators have struggled for years to monitor increasingly far-flung supply chains, particularly those of the pharmaceutical industry.

More than 90% of the drugs prescribed in the U.S. are generics, and over time, most drugmakers have moved their manufacturing to Asia and other regions to take advantage of cheaper labor and materials.

The FDA's oversight of foreign plants has come under renewed scrutiny since 2018, with dozens of recalls triggered by traces of cancer-causing chemicals found in medications for blood pressure and other common conditions.

In December, the Government Accountability Office reported that FDA's foreign inspections have fallen 13% since since fiscal 2016, in part, due to staffing shortages.

The global disruptions tied to coronavirus have sparked concerns that shuttered plants in China, India and other nations could cause drug and medical supply shortages in the U.S. A delay in inspections could potentially exacerbate those problems because plants that have had manufacturing violations in the past must pass FDA requirements to resume exports to the U.S.

FDA Commissioner Stephen Hahn said the agency would use alternative methods to monitor the safety of imports, including sampling products at U.S. ports and relying on inspection information from other countries. Hahn said the agency will consider conducting “mission-critical” inspections on a case-by-case basis.

"We stand ready to resume foreign inspections as soon as feasible," Hahn said in a statement.

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